Healthcare Industry News: stent thrombosis
News Release - May 22, 2007
CYPHER(R) Sirolimus-Eluting Coronary Stent Had Similar Results to Bypass Surgery and Better Outcomes Than Bare Metal Stents in Subgroup Analysis of Diabetic Patients With Multivessel Coronary DiseaseBARCELONA, Spain, May 22 (HSMN NewsFeed) -- A three-year follow-up subset analysis presented today as a late-breaking clinical trial at EuroPCR 2007 showed that the CYPHER® Sirolimus-eluting Coronary Stent had results comparable to coronary artery bypass grafting (CABG or bypass surgery) and better outcomes than bare metal stents (BMS) in diabetic patients with blockages in two or more coronary arteries.
The CYPHER® Stent results in the diabetic population of the ARTS II Study showed no significant difference in major adverse cardiac and cerebrovascular events (MACCE) compared to the CABG arm of the ARTS I Study (27.7 percent versus 17.7 percent, respectively; p = 0.10). In addition, the analysis showed that the CYPHER® Stent performed significantly better than the BMS arm of the ARTS I Study, as 47.3 percent of the patients who received a BMS experienced a MACCE event after three years (p < 0.001). These findings are significant as MACCE -- comprised of death, stroke, myocardial infarction (heart attack) and the need for repeat revascularization (re-treatment) of the blocked artery -- was the primary endpoint of the ARTS II Study.
Sponsored by Cordis Corporation, the ARTS II Study was designed to determine whether the clinical and cost-effectiveness outcomes with the CYPHER® Stent in 607 patients with multivessel coronary disease were non- inferior to the results obtained in the ARTS I Study, which was conducted in 1997 and included 605 patients treated with bypass surgery and 600 patients treated with a BMS. In the diabetic subgroup analysis, investigators compared the findings for the 159 diabetic patients in the ARTS II Study to those from the ARTS I Study, which included 96 diabetic patients treated with bypass surgery and 112 treated with a BMS. The risk profile of the patients in the ARTS II Study was significantly higher compared to the risk profile of the patients in the ARTS I Study.
"Patients with multivessel disease and diabetes represent some of the most complex cases to treat," said Keith D Dawkins, M.D., F.R.C.P., F.A.C.C., from Southampton University Hospital, who presented the analysis at EuroPCR 2007. "These findings suggest that the CYPHER® Stent may be a viable, less invasive treatment alternative for these very challenging cases."
After three years of follow-up, the overall patient population treated with the CYPHER® Stent in the ARTS II Study also continued to show similar rates of freedom from MACCE than the patients treated with bypass surgery in the ARTS I Study. Specifically, 80.6 percent of the overall patient population who received the CYPHER® Stent remained free of MACCE, compared to 83.8 percent of the patients who underwent bypass surgery. Additionally, the CYPHER® Stent performed considerably better than the ARTS I BMS arm in the same endpoint, as 66.0 percent of the patients who received a BMS did not experience a MACCE event after three years. The difference between the CYPHER® Stent arm and the BMS arm reached statistical significance (p < 0.001).
"Close to 30 years ago, balloon angioplasty transformed the treatment paradigm for patients with coronary artery disease," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division of Cordis Corporation. "This three-year analysis suggests that balloon angioplasty combined with the CYPHER® Stent may be a viable alternative to bypass surgery for non-diabetic and diabetic patients with multivessel coronary disease."
The ARTS II Study investigators also reported stent thrombosis rates using the Academic Research Consortium (ARC) definition. The definite stent thrombosis rate for the CYPHER® Stent in the diabetic patient population 30 days after implantation was significantly lower than the rate in the bare metal stent arm of the ARTS I Study (1.3 percent versus 7.1 percent, respectively; p = 0.018). Three-year stent thrombosis comparisons with the BMS arm were not possible, as the ARTS I Study did not track stent thrombosis rates beyond 30 days. The cumulative rates of definite stent thrombosis for the CYPHER® Stent at three-year follow-up in the overall ARTS II Study patient population was 3.3 percent. Investigators did not find significant differences in the stent thrombosis rates between the ARTS II diabetic and non-diabetic patients using any of the ARC definitions.
The CYPHER® Stent does not have an approved indication in the United States for diabetic patients or patients with multivessel coronary disease.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER® SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at http://www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at http://www.cordis.com.
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
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